We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrocardiographic Mapping and Imaging

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394965
First Posted: July 15, 2011
Last Update Posted: October 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Samuel J. Asirvatham, Mayo Clinic
  Purpose
The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging methodology for localizing and imaging cardiac electrical activity from body surface electrocardiographic recordings in patients with ventricular tachycardia (VT). Using non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.

Condition Intervention Phase
Cardiac Arrhythmia Procedure: ECG electrodes Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Electrocardiographic Mapping and Imaging

Resource links provided by NLM:


Further study details as provided by Samuel J. Asirvatham, Mayo Clinic:

Primary Outcome Measures:
  • Results of ECG Mapping [ Time Frame: 1 year ]
    Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals


Enrollment: 0
Study Start Date: October 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ECG Mapping Procedure: ECG electrodes
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
Other Names:
  • Electrode strips
  • Electrode patches

Detailed Description:

Specific Aims

1. Use non-invasive cardiac electric imaging to provide information as to the sites of origin of arrhythmias and sequence of cardiac activation and repolarization.

Methods and Procedures Approximately 8 patients with recorded Premature Ventricular Contractions (PVC), Wolff-Parkinson-White (WPW) or other ventricular tachycardia cases which need Ensite/Carto endocardial mapping and radiofrequency ablation treatment will be enrolled.

One day before catheterization and ablation, patients will undergo approximately 30 minutes of Body Surface Potential Mapping (BSPM) recordings with about 200 surface electrodes arranged in 20 strips, attached on his/her front and back. BSPMs will be recorded in the baseline resting rhythm.

On the day of ablation, before catheterization in the surgical room, the BSPM recording procedure will be carried out with the patient using the same technique used during the first BSPM study.

Clinical endocardial mapping data may also be obtained concurrently with BSPM recordings before the ablation procedure.

Another BSPM recording will be made 30-60 minutes after successful ablation with the patient still in normal sinus rhythm if possible. Patients will be followed up 1 month after ablation with the same method of BSPM recorded at the baseline resting rhythm.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Any patient undergoing ablation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394965


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Samuel Asirvatham, MD Mayo Clinic
  More Information

Responsible Party: Samuel J. Asirvatham, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01394965     History of Changes
Other Study ID Numbers: 10-004825
First Submitted: July 7, 2011
First Posted: July 15, 2011
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Samuel J. Asirvatham, Mayo Clinic:
ECG
Mapping
ecg mapping
arrythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes


To Top